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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00629304 |
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Date of registration:
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26/02/2008 |
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Primary sponsor: |
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Public title:
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Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
TELEDIAB-1 |
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Scientific title:
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Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00629304 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Yves BENHAMOU, MD PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- type 1 diabetes mellitus for = 12 months or more (including C-peptide negative
secondary diabetes)
- age > 18 y.o.
- intensive insulin basal-bolus therapy for = 6 months. At inclusion, patients should
be treated, either with a combination of a basal, long-acting insulin and insulin
rapid analog before each meal, or with rapid insulin analog delivered with a pump
- chronically uncontrolled diabetes with HbA1c = 8 % during the past 12 months and at
inclusion
Exclusion Criteria:
- patient with unstable associated evolutive pathology
- patient who need a more frequent diabetic follow up (than in the protocol)
- patient with a education teaching within the 3 months before inclusion
- patient with a hemoglobinopathy
- patient with toxicomania, alcoholism or psychological troubles
- type 2 diabetes patients
- patient who don't need strict metabolic objectives
- pregnant or parturient women
- person with no freedom (prisoner)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes
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Intervention(s)
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Device: PDA-FIT System + telephone follow-up
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Device: placebo
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Device: VISITS + PDA-FIT system
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Primary Outcome(s)
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Comparison of HbA1c mean between the 3 groups
[Time Frame: at 6 months]
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Secondary Outcome(s)
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8-point blood glucose profiles at inclusion and 6 months
[Time Frame: inclusion and M6]
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Absolute HbA1c differences (M0-M6)
[Time Frame: inclusion and M6]
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Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician
[Time Frame: 6 months]
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Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
[Time Frame: study period]
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Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit
[Time Frame: week before inclusion and prior to M6]
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HbA1c changes at M0, M3 and M6
[Time Frame: inclusion, M3 and M6]
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Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory
[Time Frame: study period]
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Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit
[Time Frame: 14 days prior to inclusion and prior to M6]
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Percentage of patients reaching HbA1c <7.5% at 6 months
[Time Frame: 6 months]
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Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire
[Time Frame: inclusion and M6]
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Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care
[Time Frame: 6 months]
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Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time
[Time Frame: study period]
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Secondary ID(s)
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DCIC 07 08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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